Robotic surgical system for protecting tissue surrounding a surgical site

ABSTRACT

Systems and methods are provided for determining acceptable ranges of pressures for use by a robotic arm on a surgical instrument, robotic systems and methods that are limited to using the acceptable ranges of pressures, and the medical devices for use in the robotic surgery. Learning software is included in the methods and systems for correlating manually-performed procedures with pressure sensors as a tactile gauge for qualifying the acceptable ranges of pressures for use by a robotic system. Robotic systems and methods are provided for (i) locating tissue borders of a surgical site, (ii) identifying a preferred pressure, and (iii) transmitting the data to the computer to avoid violating the integrity of tissue surrounding the surgical site.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation application of U.S. application Ser. No.16/258,517, filed Jan. 25, 2019, which claims priority to U.S.Provisional Application No. 62/622,112, filed Jan. 25, 2018, each ofwhich is hereby incorporated herein by reference in its entirety.

BACKGROUND Field of the Invention

The present disclosure relates generally to robotic surgery, and moreparticularly to a system and related method for designing a roboticsurgical procedure, for example, removal of spinal disc material androbotic endplate preparation during a spinal procedure.

Description of Related Art

One problem to address in establishing robotic surgical procedures isthe pressure that the robotic arm applies on a surgical instrument incontact with tissue. One of skill will appreciate the value of having amethod and system for qualifying an acceptable range of pressuresapplied to a functional portion of a surgical instrument against ananimal tissue, for example, as well as the robotic systems and methodsthat can be derived from such a method.

By way of example only, the robotic vertebral endplate preparationsystem described herein includes a manual disc removal instrument, arobotic endplate preparation instrument, and a computer system.Optionally, the robotic vertebral endplate preparation system mayfurther include a manual data input device, and/or a video display. Themanual disc removal instrument is manually operable by a user (e.g.surgeon) to remove intervertebral disc material in a traditional manner(e.g. moved or rotated). The manual disc removal instrument is alsoequipped with one or more sensors to gather data related to the locationof the annular borders and/or the preferred pressure for endplatepreparation, and transmit the gathered data to the computer system inreal-time (or alternatively store the data to be uploaded to thecomputer system upon completion of the data gathering). The computersystem processes the annular border location and pressure data and tocreate a virtual model of the patient's annulus fibrosus to later informthe robotic endplate preparation instrument on the physical boundariesof the annulus as well as the preferred pressure to apply for preciseand efficient preparation of the endplates. Optionally, the manual datainput device (e.g. desktop computer, laptop computer, handheld tabletcomputer and/or smart-phone, and the like) may be used to manually inputadditional data points not obtained by the sensor. The video display(e.g. video monitor, desktop computer, laptop computer, tablet computer,and/or smart-phone) may show the real-time creation of the virtual modelfor instant visual feedback.

One of skill will appreciate having systems and methods for solving theabove problems, and taking advantage of the opportunities available inthe art of robotic surgical procedures including, for example, systemsand methods that avoid violating the integrity of the tissue, such astissue surrounding a surgical site that a surgeon wants to preserve. Anexample would be the vertebral endplate bone surrounding anintervertebral space. As such, one of skill will appreciate having (i) asystem for qualifying an acceptable range of pressures applied to afunctional portion of a surgical instrument against an animal tissue,and (ii) a method of qualifying a range of acceptable pressures forapplying a functional portion of a surgical instrument against an animaltissue, as well as (iii) a robotic system calibrated to apply a range ofacceptable pressures to an animal tissue through a functional portion ofa surgical instrument.

SUMMARY

The technology provided herein includes, for example, systems andmethods for determining acceptable ranges of pressures for use by arobotic arm on a surgical instrument, robotic systems and methods thatare limited to using the acceptable ranges of pressures, and the medicaldevices for use in the robotic surgery. One of skill will appreciate,for example, that learning software is included in the methods andsystems for correlating manually-performed procedures with pressuresensors as a tactile gauge for qualifying the acceptable ranges ofpressures for use by a robotic system, at least in some embodiments.

A system for qualifying an acceptable range of pressures applied to afunctional portion of a surgical instrument against an animal tissue caninclude, for example, a surgical instrument having a functional portionthat contacts an animal tissue through application of pressure by anoperator of the surgical instrument; and, a pressure sensor in anoperable association with the functional portion operable to measure thepressure applied by the operator to the functional portion in contactwith the tissue. One of skill will appreciate that the systems can alsoinclude a computer system having a processor; and, a memory. The memorycan be configured to include, for example, a pressure module on anon-transitory computer readable storage medium operable to createpressure data representing the pressure applied by the operator to thefunctional portion in contact with the tissue; and, a database on anon-transitory computer readable storage medium operable to store thepressure data.

In some embodiments, the system can further include an input module on anon-transitory computer readable storage medium. The input module can,for example, receive input from an operator. The operator input can beused in identifying, for example, any surgical parameters of interest toa particular surgical procedure. For example, the operator input caninclude, the type of tissue receiving the pressure applied by theoperator, the type of function obtained by the functional portion on thetissue receiving the pressure applied by the operator; or, the type ofresult, including a positive result and/or a negative result, of thepressure applied to the functional portion on the tissue receiving thepressure applied by the operator; or, a combination thereof of any ofthe parameters of interest.

In some embodiments, the system can further include a design module on anon-transitory computer readable storage medium operable forestablishing a pressure output, or perhaps a pressure profile outputcorresponding to a range of acceptable pressures for use in contactingthe type of tissue, to obtain the type of function, and the positiveresults, when contacting the functional portion with the tissue.

One of skill will appreciate that the systems and methods providedherein can be used to qualify the range of acceptable pressures for justabout any type of surgical instrument that is used by applying apressure to a tissue. For example, the surgical instrument can be acutting instrument or a dissecting instrument, a grasping instrument ora holding instrument, a hemostatic instrument, a retraction instrument,or a tissue-unifying instrument.

The systems and methods can be used, in particular, to qualify the rangeof acceptable pressures for the functional portion of a spinal surgicalinstrument that is configured, for example, to remove intervertebraltissue. In some embodiments, for example, the surgical instrument can beconfigured for removal of nucleus pulposus, disc annulus, cartilaginousendplate, ligaments and fascia, or any combination thereof. In someembodiments, the surgical instrument is configured for removal of theintervertebral tissue without violating the integrity of the corticalportion of (i) the top vertebral plate or (ii) the bottom vertebralplate of an intervertebral space, wherein the removing includes limitingthe pressure applied on the functional portion of the surgicalinstrument to the intervertebral tissue to a pressure from within therange of acceptable pressures.

One of skill will appreciate that the systems and methods can use anysource of pressure to qualify the range of acceptable pressures. In someembodiments, the operator is a human, such that a human becomes atactile gauge to help identify the range of acceptable pressures. Insome embodiments, the operator is a mechanical device, such that amechanical device becomes a tactile gauge to help identify the range ofacceptable pressures. For example, a mechanical device can be anymechanical device used in in vivo, in vitro, or in situ procedures toapply and measure a mechanical pressure placed on a tissue. In someembodiments, for example, the mechanical device can be a robotic arm.

A method of qualifying a range of acceptable pressures is also providedfor applying a functional portion of a surgical instrument against ananimal tissue. The method can include, for example, obtaining a surgicalinstrument having a functional portion configured for contacting ananimal tissue with a pressure applied by an operator of the surgicalinstrument, the functional portion of the surgical instrument being inan operable association with a pressure sensor for measuring thepressure applied by the operator to the functional portion in contactwith the tissue; contacting the functional portion of the surgicalinstrument with the tissue of the animal with a total range ofpressures; and, analyzing pressure data representing the total range ofpressures. One of skill will appreciate that a computer can be used insome embodiments to analyze the data. The computer can have a processorand a memory, and the memory can have a pressure module on anon-transitory computer readable storage medium and a database on anon-transitory computer readable storage medium.

In some embodiments, the analyzing can include creating the pressuredata with the pressure module, the pressure data representing thepressure applied by the operator to the functional portion in contactwith the tissue; and, storing the pressure data on the database. Themethod steps can be designed, whether using a computer or otherwise, foruse in the selecting a range of acceptable pressures for use incontacting the functional portion with the animal tissue.

The methods can further include correlating operator input with theresults obtained from contacting the functional portion with the animaltissue, the correlating including, for example, receiving the operatorinput with an input module on a non-transitory computer readable storagemedium; and identifying the type of tissue receiving the pressureapplied by the operator, the type of function obtained by the functionalportion on the tissue receiving the pressure applied by the operator,the type of result, including a positive result and/or a negativeresult, of the pressure applied through the functional portion on theanimal tissue; or, a combination thereof.

The methods can further include designing a pressure profile using adesign module on a non-transitory computer readable storage mediumoperable for establishing a pressure profile output that identifies arange of acceptable pressures for use in contacting the type of tissue,to obtain the type of function, and the positive results, whencontacting the functional portion with the tissue.

A robotic system can be created, using the systems and methods herein,to apply a range of acceptable pressures to an animal tissue through afunctional portion of a surgical instrument. Such a system can include,for example, a surgical instrument having a functional portion, arobotic arm configured for holding the surgical instrument andcontacting the functional portion of the surgical instrument with ananimal tissue using a pressure from within a range of acceptablepressures, a pressure application component operably coupled to therobot arm to apply the pressure from within the range of acceptablepressures when contacting the functional portion with the animal tissue.A computer can be included, and the computer can have a processor; and,a memory, wherein the memory can be configured to include, for example,a governing module on a non-transitory computer readable storage medium.The governing module can be configured such that it is operable toinstruct the processor to limit any pressure applied by the robotic armon the functional portion of the surgical instrument to fall within therange of acceptable pressures when contacting the functional portionwith the animal tissue.

As with the qualifying methods and systems provided herein, one of skillwill appreciate that the robotic systems and methods provided herein canimplement the range of acceptable pressures with just about any type ofsurgical instrument that is used by applying a pressure to a tissue. Forexample, the surgical instrument can be a cutting instrument or adissecting instrument, a grasping instrument or a holding instrument, ahemostatic instrument, a retraction instrument, or a tissue-unifyinginstrument.

The tissue of interest in the surgical procedure can includeintervertebral tissue and cortical portion of a vertebral endplate, insome embodiments, and the functional portion of the surgical instrumentcan be configured to remove the intervertebral tissue, and theacceptable range of pressures can be designed to remove theintervertebral tissue without violating the cortical portion of thevertebral endplate. As such, the pressures applied on surgicalinstruments contacting tissue can be limited, for example, to what hasbeen qualified to an acceptable range of pressures, as well as precise.It should be appreciated, however, that the systems and methods providedherein can be considered customizable to achieve any desired result,whether or not designed to be limited to an acceptable range ofpressures, in order to obtain a desired result for any particularsurgical procedure. In some embodiments, for example, a system or methodmay be designed to exceed what is otherwise considered to be anacceptable range of pressures, as it may be desired to have thefunctional portion of the surgical instrument achieve what was otherwisean undesired result. In some embodiments, for example, it may be desiredto violate the integrity of a tissue, such as a bone tissue, whereas theacceptable range of pressures was qualified to avoid such a result.

In particular, however, a method of using the robotic systems taughtherein can be controlled to prepare an intervertebral disc for a spinalfusion procedure. The procedure can be controlled to avoid violating theintegrity of the cortical portion of a vertebral endplate, for example.Such a method might include, for example, creating a point of entry intoan intervertebral disc, the intervertebral disc having a nucleuspulposus surrounded by an annulus fibrosis; and, removing theintervertebral tissue from within the intervertebral space, theintervertebral space having a top vertebral plate and a bottom vertebralplate while preserving the annulus fibrosis and without violating theintegrity of the cortical portion of (i) the top vertebral plate or (ii)the bottom vertebral plate, wherein the removing includes limiting thepressure applied by the robotic arm on the functional portion of thesurgical instrument to the intervertebral tissue to a pressure fromwithin the range of acceptable pressures.

In some embodiments, the method can be part of a spinal fusion procedurethat uses a scaffolding to support fusion of an intervertebral discspace, such that the method can further include inserting a scaffoldingthrough the point of entry into the intervertebral space; and, adding agrafting material to the intervertebral space for the fusion.

BRIEF DESCRIPTION OF THE DRAWINGS

Many advantages of the present disclosure will be apparent to thoseskilled in the art with a reading of this specification in conjunctionwith the attached drawings, wherein like reference numerals are appliedto like elements and wherein:

FIG. 1 is a graphical representation of an exemplary robotic vertebralendplate preparation system, according to some embodiments;

FIG. 2 is a flowchart illustrating one example of a method of performingrobotic endplate preparation during a spinal procedure using the roboticvertebral endplate preparation system of FIG. 1 , according to someembodiments;

FIG. 3 is a perspective view of an example of the manual disc removalinstrument of FIG. 1 in use within an intervertebral disc, according tosome embodiments;

FIG. 4 is a perspective view of an example of the robotic endplatepreparation instrument of FIG. 1 in use within an intervertebral disc,according to some embodiments;

FIG. 5 is a perspective view of an example of a digital expandable trialinstrument according to one embodiment of the disclosure, according tosome embodiments;

FIG. 6 is a top perspective view of the distal end of the digitalexpandable trial instrument of FIG. 5 , according to some embodiments;

FIG. 7 is a bottom perspective view of the distal end of the digitalexpandable trial instrument of FIG. 6 , according to some embodiments;

FIG. 8 is a flowchart illustrating one example of a method of performingrobotic implant insertion and expansion during a spinal procedureaccording to one embodiment of the disclosure, according to someembodiments; and,

FIG. 9 is a block diagram of computer systems forming part of roboticvertebral endplate preparation system of FIG. 1 , according to someembodiments.

DETAILED DESCRIPTION

Illustrative embodiments of the invention are described below. In theinterest of clarity, not all features of an actual implementation aredescribed in this specification. It will of course be appreciated thatin the development of any such actual embodiment, numerousimplementation-specific decisions must be made to achieve thedevelopers' specific goals, such as compliance with system-related andbusiness-related constraints, which will vary from one implementation toanother. Moreover, it will be appreciated that such a development effortmight be complex and time-consuming, but would nevertheless be a routineundertaking for those of ordinary skill in the art having the benefit ofthis disclosure. The systems and methods disclosed herein boast avariety of inventive features and components that warrant patentprotection, both individually and in combination.

Systems and methods are provided herein for determining acceptableranges of pressures for use by a robotic arm on a surgical instrument,robotic systems and methods that are limited to using the acceptableranges of pressures, and the medical devices for use in the roboticsurgery. One of skill will appreciate, for example, that learningsoftware is included in the methods and systems for correlatingmanually-performed procedures with pressure sensors as a tactile gaugefor qualifying the acceptable ranges of pressures for use by a roboticsystem, at least in some embodiments. For purposes of this teaching,“qualifying” or “qualified” can include, for example, any experimentaldetermination performed using the methods taught herein, which make itreasonable for a person of ordinary skill in the art of surgicalprocedures, and/or robotics, to believe that the results of applying the“acceptable” range of pressures would, for example, produce desirableresults, in some embodiments, or would not result in a failure of thesurgical procedure, in some embodiments.

A system for qualifying an acceptable range of pressures applied to afunctional portion of a surgical instrument against an animal tissue caninclude, for example, a surgical instrument having a functional portionthat contacts an animal tissue through application of pressure by anoperator of the surgical instrument; and, a pressure sensor in anoperable association with the functional portion operable to measure thepressure applied by the operator to the functional portion in contactwith the tissue. One of skill will appreciate that the systems andmethods can use any source of pressure to qualify the range ofacceptable pressures. In some embodiments, the operator can be a human,such as a researcher, a medical doctor, or a surgeon, for example. Thehuman can be used to help identify the range of acceptable pressures, asa tactile gauge and/or a source of tactile data. Tactile data can beused, for example, as a source of data to determine the range ofacceptable pressures. In some embodiments, the operator can be amechanical device, such that a mechanical device becomes a tactile gaugeto help identify the range of acceptable pressures. For example, amechanical device can be any mechanical device used in in vivo, invitro, or in situ procedures to apply and measure a mechanical pressureplaced on a tissue. In some embodiments, for example, the mechanicaldevice can be a robotic arm as a tactile gauge, and/or a source oftactile data. In some embodiments, the operator can be a combination ofa human and a mechanical device. For example, a human can operate arobotic arm, or other mechanical source of motion and pressure, and usethe combination to provide a tactile gauge and a testimonial or measuredresponse as a tactile gauge, and/or a source of tactile data, in someembodiments.

One of skill will appreciate that the systems can also include acomputer system having a processor; and, a memory. The memory can beconfigured to include, for example, a pressure module on anon-transitory computer readable storage medium operable to createpressure data representing the pressure applied by the operator to thefunctional portion in contact with the tissue; and, a database on anon-transitory computer readable storage medium operable to store thepressure data.

One of skill will appreciate that the systems and methods providedherein can be used to qualify the range of acceptable pressures for justabout any type of surgical instrument that is used by applying apressure to a tissue. For example, the surgical instrument can be acutting instrument or a dissecting instrument, a grasping instrument ora holding instrument, a hemostatic instrument, a retraction instrument,or a tissue-unifying instrument. Accordingly, one of skill willappreciate that the “functional portion” of the surgical instrument willinclude the portion of the surgical device that may be configured to dothe “function”, which can be, for example, the cutting or dissecting,the grasping or holding, the retracting, the tissue-unifying, thepreventing of the flow of blood, or a combination thereof.

The term “animal” can be used interchangeably, in some embodiments, withthe terms “subject” and “patient”. Such terms can be used to refer to ananimal such as a mammal including, but not limited to, non-primates suchas, for example, a cow, pig, horse, cat, dog, rat and mouse; andprimates such as, for example, a monkey or a human. As such, the terms“subject” and “patient” can also be applied to non-human biologicapplications including, but not limited to, veterinary, companionanimals, commercial livestock, and the like. As such, “tissue” can beused to refer, for example, to epithelial tissue, connective tissue,muscle tissue and/or nerve tissue, in some embodiments. One of skillwill appreciate that epithelial tissues form the surface of the skin,and line many cavities of the body and covers the internal organs;connective tissue includes cartilage, bone, adipose, and blood, of whichcartilage and bone are of particular focus herein; muscle tissueincludes skeletal, smooth, and cardiac muscle; and the neural tissuesinclude neurons that process and transfer information throughout asubject's body.

The tissue of interest in the surgical procedure can include, forexample, intervertebral tissue and cortical portion of a vertebralendplate, in some embodiments. The functional portion of the surgicalinstrument can be configured, for example, to remove the intervertebraltissue. And, in some embodiments, the acceptable range of pressures canbe designed to remove the intervertebral tissue without violating thecortical portion of the vertebral endplate. As such, the pressuresapplied on surgical instruments contacting tissue can be limited, forexample, to what has been qualified to an acceptable range of pressures,as well as precise.

It should be appreciated, however, that the systems and methods providedherein can be considered customizable to achieve any desired result,whether or not designed to be limited to an acceptable range ofpressures, in order to obtain a desired result for any particularsurgical procedure. In some embodiments, for example, a system or methodmay be designed to exceed what is otherwise considered to be anacceptable range of pressures, as it may be desired to have thefunctional portion of the surgical instrument achieve what was otherwisean undesired result. In some embodiments, for example, it may be desiredto violate the integrity of a tissue, such as a bone tissue, whereas theacceptable range of pressures was qualified to avoid such a result.

In particular, however, a method of using the robotic systems taughtherein can be controlled to prepare an intervertebral disc for a spinalfusion procedure. The procedure can be controlled to avoid violating theintegrity of the cortical portion of a vertebral endplate, for example.Such a method might include, for example, creating a point of entry intoan intervertebral disc, the intervertebral disc having a nucleuspulposus surrounded by an annulus fibrosis; and, removing theintervertebral tissue from within the intervertebral space, theintervertebral space having a top vertebral plate and a bottom vertebralplate while preserving the annulus fibrosis and without violating theintegrity of the cortical portion of (i) the top vertebral plate or (ii)the bottom vertebral plate, wherein the removing includes limiting thepressure applied by the robotic arm on the functional portion of thesurgical instrument to the intervertebral tissue to a pressure fromwithin the range of acceptable pressures.

In some embodiments, the method can be part of a spinal fusion procedurethat uses a scaffolding to support fusion of an intervertebral discspace, such that the method can further include inserting a scaffoldingthrough the point of entry into the intervertebral space; and, adding agrafting material to the intervertebral space for the fusion.

Moreover, one of skill will understand that the methods and systemsprovided herein can include hardware and software, in some embodiments,the combination of which can a “computer”, for example, having aprocessor and memory. It should also be understood that the technologyprovided herein also includes “software”, which can include instructionsfor execution of function by the processor, the software including, forexample, a set of modules, engines, and instructions for executing themodules and/or engines by the processor. As such, in some embodiments,the system can further include an input module on a non-transitorycomputer readable storage medium. The input module can, for example,receive input from an “operator”. The operator input can be used inidentifying, for example, any surgical parameters of interest to aparticular surgical procedure. For example, the operator input caninclude, the type of tissue receiving the pressure applied by theoperator, the type of function obtained by the functional portion on thetissue receiving the pressure applied by the operator; or, the type ofresult, including a “positive result” and/or a “negative result”, of thepressure applied to the functional portion on the tissue receiving thepressure applied by the operator; or, a combination thereof of any ofthe parameters of interest.

In some embodiments, the results can be expressed as “desirable”. A“desirable result”, in some embodiments, may be one that does not (i)represent a failure of the surgical procedure, or perhaps (ii) create anundue risk of future failure of the surgical procedure downstream forthe subject undergoing the procedure, for example.

In some embodiments, the results can be expressed as a “positive”. Oneof skill will understand that a “positive result” can be, for example,any surgical result obtained that is desired when contacting thefunctional portion of the surgical instrument with the tissue. Apossible positive result may be the removal of connective tissue, suchas fascia or cartilaginous tissue from the cortical portion of a bonewithout violating the cortical portion of the bone, or the integrity ofthe cortical portion of the bone, for example. In some embodiments, thetissue can be intervertebral tissue, for example, such as nucleuspulposus, disc annulus, cartilaginous endplate, ligaments and fascia, orany combination thereof, and the bone can be a vertebral endplate. Insome embodiments, the tissue can be cartilaginous tissue, and the bonecan be a tibial plateau or a femoral condyle. In some embodiments, thetissue can be cartilaginous tissue, and the bone can be a mandibularcondyle, or a temporomandibular socket. A possible negative result couldinclude for example, an attempt at the removal of the connective tissuefrom the cortical potion of the bone while, undesirably, violating thecortical portion of the bone. A “negative result” could be, for example,any undesirable result that was experience in the surgical procedurethat was a result of an application of pressure through the functionalportion of the surgical instrument when contacting the tissue with thefunctional portion.

In some embodiments, an “undesirable result” is anything less than a100% positive result, 1% less than a 100% positive result, 2% less thana 100% positive result, 5% less than a 100% positive result, 10% lessthan a 100% positive result, 15% less than a 100% positive result, 25%less than a 100% positive result, 50% less than a 100% positive result,or any amount or range therein in increments of 0.1%. In someembodiments, a 100% positive result can be considered removal of asufficient amount of connective tissue from a bone, for example, withoutremoving any of the cortical portion of the bone.

The contrast is also used. For example, in some embodiments, an“desirable result” is anything less than a 100% negative result, 1% lessthan a 100% negative result, 2% less than a 100% negative result, 5%less than a 100% negative result, 10% less than a 100% negative result,15% less than a 100% negative result, 25% less than a 100% negativeresult, 50% less than a 100% negative result, or any amount or rangetherein in increments of 0.1%. In some embodiments, a 100% negativeresult can be considered removal of a sufficient amount of a corticalportion of a bone to result in a failure of the surgical procedure.

As such, a “successful” a surgical procedure can be considered, in someembodiments, a lack of a significant loss of the integrity of a corticalportion of a bone, such that the structural integrity of the corticalportion of the bone at the surgical site remains sufficient for thesurgical procedure to function as intended. However, a “failure” of asurgical procedure can be considered the point at which the integrity ofthe cortical portion of the bone was sufficiently lost, such that thecortical portion of the bone failed to support the local anatomicalstructure to the extent needed for the surgical procedure to function asintended. In a spinal fusion, for example, a failure can be consideredthe point at which the integrity of the cortical portion of thevertebral endplate failed to support to pressure applied to it by acage, or a vertebral implant, or a scaffolding, in some embodiments. Thepercentage of a positive result, for example, can be measured relativeto the total amount, or range of amounts, of a cortical portion of bonethat one of ordinary skill would be expect to result in such a failureof the surgical procedure, if removed.

As such, the input module can be used to provide operator input in theform of, of example, tactile data that relates to such success orfailure, or any such input, in order to better assess the range ofacceptable pressures that can be applied through the functional portionof the surgical instrument in contact with the tissue. In someembodiments, the system can further include a design module on anon-transitory computer readable storage medium operable forestablishing a pressure output, or perhaps a pressure profile outputcorresponding to a range of acceptable pressures for use in contactingthe type of tissue, to obtain the type of function, and the positiveresults, when contacting the functional portion with the tissue. One ofskill will appreciate that a pressure output can include a singlepressure value, whereas a pressure profile output can include a set ofpressures that provide information regarding the range of pressures usedas a tactile gauge that can be correlated, for example, with the tactiledata, or results obtained during, or ultimately, from the surgicalprocedure.

One of skill will appreciate that any suitable pressure sensor known tothose of skill in the art can be used, the selection of which can beconsidered particular to the application in which the sensor is used,and the environment in which the sensor is placed. Examples of sensorsinclude, but are not limited to, a blade sensor, a beam and forcesensor, a hermetic strain gauge, a plunger sensor, a torque and powermeter sensor, a strain gauge. One of skill will appreciate thattransducers can be used, for example, to convert analog data intodigital data, which can be useful in the integration of computer systemsto the technology taught herein, in some embodiments.

As such, a method of qualifying a range of acceptable pressures is alsoprovided for applying a functional portion of a surgical instrumentagainst an animal tissue. The method can include, for example, obtaininga surgical instrument having a functional portion configured forcontacting an animal tissue with a pressure applied by an operator ofthe surgical instrument, the functional portion of the surgicalinstrument being in an operable association with a pressure sensor formeasuring the pressure applied by the operator to the functional portionin contact with the tissue; contacting the functional portion of thesurgical instrument with the tissue of the animal with a total range ofpressures; and, analyzing pressure data representing the total range ofpressures. One of skill will appreciate that a computer can be used insome embodiments to analyze the data. The computer can have a processorand a memory, and the memory can have a pressure module on anon-transitory computer readable storage medium and a database on anon-transitory computer readable storage medium.

And, in some embodiments, the analyzing can include creating thepressure data with the pressure module, the pressure data representingthe pressure applied by the operator to the functional portion incontact with the tissue; and, storing the pressure data on the database.The method steps can be designed, whether using a computer or otherwise,for use in the selecting a range of acceptable pressures for use incontacting the functional portion with the animal tissue.

The methods can further include correlating operator input with theresults obtained from contacting the functional portion with the animaltissue, the correlating including, for example, receiving the operatorinput with an input module on a non-transitory computer readable storagemedium; and identifying the type of tissue receiving the pressureapplied by the operator, the type of function obtained by the functionalportion on the tissue receiving the pressure applied by the operator,the type of result, including a positive result and/or a negativeresult, of the pressure applied through the functional portion on theanimal tissue; or, a combination thereof.

The methods can further include designing a pressure profile using adesign module on a non-transitory computer readable storage mediumoperable for establishing a pressure profile output that identifies arange of acceptable pressures for use in contacting the type of tissue,to obtain the type of function, and the positive results, whencontacting the functional portion with the tissue.

As such, the systems and methods can be used, in some embodiments, toqualify the range of acceptable pressures for the functional portion ofa spinal surgical instrument that is configured, for example, to removeintervertebral tissue. In some embodiments, for example, the surgicalinstrument can be configured for removal of nucleus pulposus, discannulus, cartilaginous endplate, ligaments and fascia, or anycombination thereof. In some embodiments, the surgical instrument isconfigured for removal of the intervertebral tissue without violatingthe integrity of the cortical portion of (i) the top vertebral plate or(ii) the bottom vertebral plate of an intervertebral space, wherein theremoving includes limiting the pressure applied on the functionalportion of the surgical instrument to the intervertebral tissue to apressure from within the range of acceptable pressures.

FIG. 1 is a graphical representation of an exemplary robotic vertebralendplate preparation system 10 according to one embodiment of thedisclosure. By way of example only, the robotic vertebral endplatepreparation system 10 includes a manual disc removal instrument 12, arobotic endplate preparation instrument 14, and a computer system 4000.Optionally, the robotic vertebral endplate preparation system mayfurther include a manual data input device 16, and/or a video display18. As will be explained, the manual disc removal instrument 10 ismanually operable by a user (e.g. surgeon) to remove intervertebral discmaterial in a traditional manner (e.g. moved or rotated). The manualdisc removal instrument 10 is also equipped with one or more sensors togather data related to the location of the annular borders and/or thepreferred pressure for endplate preparation, and transmit the gathereddata to the computer system 4000 in real-time (or alternatively storethe data to be uploaded to the computer system 4000 upon completion ofthe data gathering). The computer system 4000 (FIG. 9 ) processes theannular border location and pressure data and to create a virtual modelof the patient's annulus fibrosus to later inform the robotic endplatepreparation instrument 14 on the physical boundaries of the annulus aswell as the preferred pressure to apply for precise and efficientpreparation of the endplates. Optionally, the manual data input device16 (e.g. desktop computer, laptop computer, handheld tablet computerand/or smart-phone, and the like) may be used to manually inputadditional data points not obtained by the sensor. The video display 18(e.g. video monitor, desktop computer, laptop computer, tablet computer,and/or smart-phone) may show the real-time creation of the virtual modelfor instant visual feedback.

Referring to FIGS. 2-4 , further description of the robotic vertebralendplate preparation system will proceed in conjunction with adescription of the exemplary method for performing automated endplatepreparation during a spinal surgery. FIG. 2 is a flowchart depicting theseveral steps of the example method. By way of example, the first step20 is to access the target disc space and create annulotomyaccess/opening. By way of example, the method is described herein in thecontext of a minimally invasive approach to the target disc spacethrough Kambin's Triangle, however target disc access may beaccomplished in any traditional manner known in the field, including butnot limited to open, percutaneous, and minimally invasive, as well asany desirable approach angle, including but not limited to anterior,posterior, posteriolateral, lateral, and Kambin's Triangle. Generally,once the target disc space has been identified and the approach angledetermined (by any suitable method known in the art), an incision ismade in the patient's skin and a surgical access corridor is establishedto the target disc space (e.g. using one or more cannulae, tissueretractors, and the like).

FIG. 3 illustrates an example of the manual disc removal instrument 12(e.g. rasp) according to one embodiment of the disclosure in use withinan intervertebral disc 30. The intervertebral disc 30 includes a nucleuspulopsus 32 (“nucleus”) surrounded by an annulus fibrosus 34 (“annulus”or “annular wall”). The annulus 34 has a thickness dimension, and assuch includes an outer boundary 36 and an inner boundary 38. Returningto the method description, once the access corridor is established, thenucleus 32 is accessed by creating a breach 40 in the annular wall 34.The user may then proceed to the next step 22, which is to manuallyremove some or all of the nucleus 32 using a disc removal instrument(e.g. the disc removal instrument 12 shown in FIG. 3 ), while at thesame time mapping the annular border and determining the preferredendplate preparation pressure. The example manual disc removalinstrument 12 of the present disclosure includes a proximal end 42,distal end 44, and an elongated shaft 46 extending between the proximaland distal ends. The proximal end 42 includes a handle 48 configured toenable manual manipulation of the instrument. The distal end 44 includesa shaped end 50 configured to enable removal of disc material positionedat the distal end of a distal extension 51. By way of example, theshaped end 50 comprises a generally round hoop configured to grab andhold disc material for removal, however other shapes and configurationsare possible within the scope of the disclosure. The distal extension 51may be straight or curved.

The distal end 44 further includes one or more sensors 52 incommunication with a computer (e.g. stationary desktop and/or laptop)and/or a hand-held computing device (e.g. smart-phone and/or tabletdevice) used within the medical environment and/or remotely. Thecommunication may be achieved by any method (e.g. via hard wire, WiFi,Bluetooth, “cloud”, and the like). The one or more sensors 52 may beconfigured to (1) establish data points corresponding to the annularborders, and (2) determine the optimal pressure for endplate preparationand/or disc removal. With regard to establishing data pointscorresponding to annular borders, the proximal end 42 of the manual discremoval instrument 12 may include a button 54 (for example) that whenactivated by a user signals the computer to capture a location datapoint. The location data point is determined by the physical location ofthe sensor 52 relative to an anatomical point of interest (e.g. one ormore annular border locations), and the computer uses the information tocreate a virtual image of the target disc space. Optionally, thecomputer may cause this virtual image to be displayed on a monitor 18 orother display device in real time (e.g. as an overlay on a fluoroscopicimage captured preoperatively) so that a user may receive instant visualconfirmation of the data point capture. In the instant example, in whichthe user intends to create a virtual image of the target disc space,several points of interest of the annular border may be captured,including but not limited to the outer boundary 36 of the annulus at ornear the breach 40, the inner boundary 38 of the annulus at or near thebreach 40, and the inner boundary 38 of the annulus at one or morepoints opposite the breach 40. To capture these additional data points,the user positions the distal end 44 near the additional points ofinterest and presses the button 54. Additional data points may be inputmanually into the computer by a user from a manual data input device 16,for example on a desktop or laptop station connected to the computer, ora touch-screen interface (e.g. user uses a stylus to draw a boundary ordata point on the screen), which is captured by the computer andcombined with the sensor-captured data points to finish the virtualimage. The computer may also (or alternatively) auto-complete thevirtual image by connecting the data points and/or using thepreoperative image overlay. Once the virtual image is complete, thecomputer has the parameters of the annular boundary, and thisinformation may be used in employing a robotic endplate preparationinstrument 14 (described below).

In addition to location determination, the one or more sensors 52 of thepresent example includes a pressure-sensing feature to enable thecomputer to determine the optimal pressure to employ on the target discspace to remove the disc and prepare endplate during the robotic portionof the method. During manual disc removal and/or endplate preparation,the one or more pressure sensors 52 continuously sense the pressurebeing applied by the user according to the user's preference (e.g. basedon user's experience and “feel”). This data is transmitted (or lateruploaded) to the computer, which then provides instructions to therobotic endplate preparation instrument 14 regarding the optimalpressure for endplate preparation.

The manual disc removal instrument 12 of the present example may includeadditional sensors (or additional functionality associated with sensors52) that sense and record (or transmit to the computer) data related tothe degree of movement of the handle 48 and/or shaft 46. The degree ofmovement of the handle 48 and/or shaft 46 may be affected by theapproach angle and/or the size of the breach 30. This recorded data isprocessed by the computer and later informs the allowed movement (ifany) of the handle/shaft of the robotic endplate preparation instrument14.

Returning to the method set forth in the flowchart of FIG. 2 , the nextstep 24 is to input the recorded data regarding annular border andpreferred endplate preparation pressure into a computer that controls arobotic system configured to perform automated endplate preparation anddisc removal. In example described above, this step occurssimultaneously with the previous step as the data collection instrumentwas described as being in communication with a computer which thenprocesses the data and instructs the automated robotic device using theprocessed annular border location and pressure data. In some instancesthe data collection instrument (e.g. manual disc removal instrument 12)may include a data collection and storage feature that is not in directcommunication with a computer that processes the data and instructs therobotic instrument 14, and thus a data transfer becomes necessary.

The next step 26 of the method is to position a robotic system such thatdeployable endplate preparation elements are within the target discspace. One example of an endplate preparation instrument 14 that may beused with a robotic system is illustrated in FIG. 4 . By way of example,the robotic endplate preparation instrument 60 of the present exampleincludes a proximal end 62, a distal end 64, and an elongated shaft 66extending between the proximal end and distal end. The proximal end 62includes a handle 68, which in turn is attached to a base (not shown).The distal end 64 includes an endplate preparation element 70 (e.g. oneor more curettes, blades, whisks, and the like) configured to engage thevertebral endplate and prepare the endplate for receiving fusionmaterial (artificial and/or biologic). The base (not shown) is mountedto a fixed location, for example the patient, a tissue retractor (ifused) or the operating table via an articulating arm. According to oneexample, the base maintains the handle 68 in a fixed position. Accordingto another example, the base may enable slight movement of the handle 68within a safe boundary of Kambin's Triangle. A data set comprising thesafe range of handle movement may be recorded by the computer during themanual disc removal step (e.g. computer recording the degree of manualmovement of the handle 48 of the manual disc remover 12) and thentranslated into movement instructions or parameters for the roboticendplate preparation instrument 60.

Once the robotic system is deployed, the next step 28 is to operate therobotic system to remove disc material and prepare endplates accordingto recorded data regarding the annular border and preferred endplatepreparation pressure. As previously described, the handle 68 is kept ina generally static position (with optional slight movement controlled bythe computer) and the endplate preparation element 70 is caused to moveindependently of the shaft. This movement may include distal extension,proximal retreat, and/or rotational movement. Because the computer“knows” where the annular borders are and also what the optimal pressureto apply to the endplates is by virtue of data collection during themanual disc removal step described above, the computer-operated roboticendplate preparation instrument 14 may prepare the endplates withgreater efficiency and precision compared to a manual operator.

The robotic endplate preparation system 10 described herein by way ofexample only is one example embodiment of using robotics to increasesafety and efficiency in techniques that require precision. Howeverrobotics may be used throughout the surgical procedure to increasesafety and efficiency to several aspects. For example, one such aspectis determining an approach trajectory and establishing an operativecorridor to a surgical target site (e.g. an intervertebral disc space).In most cases, this aspect is performed manually by a surgeon who neverleaves the X-ray field even though numerous (and in some instances,continuous) radiation exposure events may happen during the procedure.This is especially hazardous for high-volume surgeons. In the currentexample, one or more surgical needles (e.g. Jamshidi needles) may beattached to the distal end(s) of one or more robotic arms controlled bycomputer system 4000 (for example). The surgeon can be out of the X-Rayfield entirely without giving up the ability to control the positioningof the surgical needle while the medial-lateral approach angle isdetermined. The robotically-positioned needle(s) may then be verifiedusing additional targeting devices/techniques. Once established, therobotic arm may then continue to hold the surgical needle (andsubsequent dilators, retractors, etc.) in place to establish andmaintain an operative corridor (e.g. minimally invasive, percutaneous,and/or open).

FIGS. 5-8 illustrate an example of a digital expandable trial instrument110 having a pressure gauge for use in determining the optimal heightexpansion of an expandable implant within a given disc space, accordingto one embodiment of the disclosure. Generally, a distal end of thedigital expandable trial instrument 110 is inserted into the prepareddisc space and then caused to expand so that it contacts the vertebralendplates. A pressure gauge positioned thereon will be activated uponcontact with the vertebral endplates, and will measure and record forcedata of the expandable trial 110 as it continues to expand and distractthe vertebra until a desired stoppage point has been reached. Theexpandable trial 110 is then returned to a contracted form and removedfrom the disc space. The information gained through the use of theexpandable trial 110 is then used when implanting and expanding anexpandable spinal implant 120 (FIG. 1 ), either manually or robotically.

By way of example, the expandable trial 110 includes an inner shaft, anouter shaft 112, an expandable wedge member 114, and a handle assembly116. The inner shaft (not shown) comprises an elongated element havingproximal and distal ends. The distal end includes an expansion elementthat interacts with the wedge member 114 to increase the height of thetop and bottom faces of the wedge member 114 as the inner shaft isdistally advanced. The proximal end includes a lever 118 extendinglaterally from the handle assembly 116. The lever 116 is operable by auser to manually facilitate advancement of the inner shaft to expand thewedge member 114.

The outer shaft 112 comprises a generally cylindrical hollow tube havinga proximal end, a distal end, and an interior lumen extendinglongitudinally through the outer shaft 112. The interior lumen is sizedand configured to receive the inner shaft therein and further enabletranslation of the inner shaft within the outer shaft 112. The proximalend of the outer shaft is attached to the handle assembly 116.

The wedge member 114 includes first and second expansion panels 120,122, and first and second pressure sensors 124, 126 associated with thefirst and second expansion panels 120, 122, respectively. The expansionpanels 120, 122 may be forced apart by the inner shaft when the usercauses the inner shaft to travel distally along the outer shaft 112.

The handle assembly 116 comprises a housing 128, a display panel 130positioned on one side of the housing 128, and an attachment member 132positioned at the proximal end of the housing 128. The lever 118 extendslaterally from the housing 128 and is connected to the inner shaftinside the housing 128. The housing 128 may include a longitudinal slotconfigured to enable translation of the lever 118 and thus expansion ofthe wedge member 114. The display panel 130 may include a first digitaldisplay unit 134 and a second display unit 136. By way of example only,the first display unit 134 may be configured to digitally display afirst data set, for example the force applied by the first and secondexpansion members 120, 122 on the vertebral endplates as communicated bythe pressure sensors 124, 126. The second display unit 136 may beconfigured to display a second data set, for example the amount ofexpansion of the first and second expansion panels 120, 122 during use.

Thus, digital expandable trial instrument 110 of the present disclosureenables a user to receive real-time information on the pressure exertedby the expandable trial on the vertebral endplates at any givenexpansion height. The user can then select the appropriate implant foruse in the procedure based on the measured pressure and height expansiondata.

In some embodiments, the digital expandable trial instrument 110 may beconfigured to be robotically operable according to instructionscommunicated to the digital expandable trial instrument 110 by computersystem 4000. In some embodiments, the housing 128 further comprises aprocessor 138 and a communications module 140. In some embodiments, theprocessor can be configured to receive data from one or more of thesensors (e.g. pressure sensors 124, 126 and/or resistance sensorsdescribed below) and programmed to act in response to certain receiveddata (e.g. stop expansion of the trial or implant when resistance sensorindicates alarm). In some embodiments, the processor can be configuredto control the operation of the digital expandable trial 110 accordingto computer code which can be, for example, stored in computer readablemedia (e.g. memory, etc.) accessible by the processor. In someembodiments, the communications module 140 can be configured to sendand/or receive data to and/or from a user device (e.g. computer, smartphone, smart watch, personal digital assistant, tablet computer, etc.).In some embodiments, the user can, via communication with the expandabletrial 110 by way of the communications module 140 and/or user inputfeature affect the operation of the expandable trial 110. Thecommunications module can be configured to communicate via a wiredand/or wireless connection with the user device via one or severalcommunications protocols or standards (e.g. Ethernet, Wi-Fi, Bluetooth,etc.).

FIG. 8 is a flowchart comprising steps of an exemplary method 150 forperforming automated insertion and expansion of an expandable implant210 using the digital expandable trial instrument 110 described hereinaccording to one embodiment of the disclosure. By way of example, thefirst step 152 is to insert the distal end of the expandable trialinstrument 110 with force sensors into the target disc space. The nextstep 154 is to record applied pressure and expansion height data duringthe expansion of the distal end of the expandable trial instrument 110.This can occur within a memory unit positioned within the housing 128 ofthe expandable trial instrument 110 or within computer system 4000. Thenext step 156 is to input the recorded data regarding applied pressureand expansion height into a computer system 4000 including a processorconfigured to process the data (if not automatically transferred) andinstruct/control a robotic system configured to perform automatedimplant insertion and expansion.

The next step 158 is to input additional patient data (e.g. age, weight,BMI, etc.) into the computer to calculate a bone density score and usethe bone density score along with acquired pressure and expansion heightdata to calculate the pressure tolerance of the patient's vertebra anddetermine optimal height expansion of implant. By way of example, thepressure tolerance may be presented to the user as a range or “safezone” including a color-coded visual indicator (e.g. green for “safe”,yellows for “caution”, red for “stop”).

The next step 160 is to position a robotic implant delivery system suchthat deployable implant elements are within the target disc space.Finally the last step 162 is to operate the robotic implant deliverysystem to insert and expand the expandable intervertebral implantaccording to calculated pressure tolerance data and determined optimalexpansion height.

One of skill should appreciate that a functioning and safe roboticsystem can be created, using the systems and methods herein, to apply arange of acceptable pressures to an animal tissue through a functionalportion of a surgical instrument. In some embodiments, the range ofacceptable pressures applied can also apply to the implantation of adevice, for example.

Such systems can include, for example, a surgical instrument having afunctional portion, a robotic arm configured for holding the surgicalinstrument and contacting the functional portion of the surgicalinstrument with an animal tissue using a pressure from within a range ofacceptable pressures, a pressure application component operably coupledto the robot arm to apply the pressure from within the range ofacceptable pressures when contacting the functional portion with theanimal tissue.

A computer can be operably attached to the systems and methods providedherein, in which the computer can have a processor; and, a memory,wherein the memory can be configured to include, for example, agoverning module on a non-transitory computer readable storage medium.The governing module can be configured such that it is operable toinstruct the processor to limit any pressure applied by the robotic arm.For example, the pressure can be limited on the functional portion ofthe surgical instrument, or implant device, to fall within the range ofacceptable pressures when contacting the functional portion with theanimal tissue.

It is important to note that even though the various method stepsdisclosed herein are driven by robotics, they are not necessarilyoccurring unsupervised, but rather trained surgeons and/or techniciansare nearby monitoring the data collection and operation of the roboticsinstrument. In the event that anything appears to be out of line forthem, they have the ability to halt the procedure (e.g. by pressing a“STOP” button or other user input to instruct the computer to stop orchange course). One advantage of using robotics to control the precisionmovements of the procedure is that the surgeons and/or technicians canbe out of the X-Ray field and still have the ability to monitor and/orcontrol the action of the robotics.

During spine procedures, one or more of the instruments and/or implantsmay penetrate (or “sink” into) the bone surface of the vertebralendplate. Too much penetration can be problematic with regard tomaintaining the integrity of the bone as well as affecting the efficacyof the procedure (e.g. too much sink may render the implantineffective). Thus in some embodiments, any one or all of the devicesdisclosed herein by way of example only (e.g. manual disc removal tool12, expandable trial 110, intervertebral implant 210, etc.) may includeone or more resistance sensors (or “stress sensors”) strategicallypositioned on vertebral contact surfaces to measure penetration intobone and alert the user if the device has over-penetrated the bone. Byway of example, the resistance sensors may be placed at certain verticalintervals (e.g. 0.5 mm intervals displaced vertically relative to thevertebral contact surface). The various devices (or coupled inserter, inthe case of an implant) may be electrified (e.g. produce or conduct anelectric current therethrough) and also include or be connected to acomponent to measure resistance (e.g. ohmmeter). The electric current isapplied and resistance measured in a continuous fashion as the device isin contact with bone. A drop in resistance signifies that devicepenetrated the bone at a level in which the resistance sensor comes intocontact with bone. In some embodiments, this may also trigger an alertor indicator to inform the user that the device has penetrated bone to acertain level. The alert or indicator may be a visual indicator (e.g.illuminated light) and/or audio indicator (e.g. alarm). In someembodiments, the device may include a plurality of visual and/or audioindicators to differentiate between depths of penetration (e.g. moreurgent alarm for deeper penetration).

In some embodiments, the robotics may be provided in a modularconfiguration, in that only the components needed for a particularprocedure are brought into the surgical space. In some embodiments, oneor more of the component may have additional sensors to detect andrecord various data, for example the total radiation exposure.

FIG. 9 is a block diagram of computing devices 4000, 4050 that may beused to implement the systems and methods described in this document, aseither a client or as a server or plurality of servers. Computing device4000 is intended to represent various forms of digital computers, suchas laptops, desktops, workstations, personal digital assistants,servers, blade servers, mainframes, and other appropriate computers.Computing device 4050 is intended to represent various forms of mobiledevices, such as personal digital assistants, cellular telephones,smartphones, and other similar computing devices. In this example,computing device 4050 may represent a handheld device, while computingdevice 4000 may represent one or ore stationary computing systemsincluding a terminal within the medical environment and/or one or moreservers that serve as the “cloud” referenced in this disclosure. Thecomponents shown here, their connections and relationships, and theirfunctions, are meant to be examples only, and are not meant to limitimplementations described and/or claimed in this document.

Computing device 4000 includes a processor 4002, memory 4004, a storagedevice 4006, a high-speed interface 4008 connecting to memory 4004 andhigh-speed expansion ports 4010, and a low speed interface 4012connecting to low speed bus 4014 and storage device 4006. Each of thecomponents 4002, 4004, 4006, 4008, 4010, and 4012, are interconnectedusing various busses, and may be mounted on a common motherboard or inother manners as appropriate. The processor 4002 can processinstructions for execution within the computing device 4000, includinginstructions stored in the memory 4004 or on the storage device 4006 todisplay graphical information for a GUI on an external input/outputdevice, such as display 4016 coupled to high-speed interface 4008. Inother implementations, multiple processors and/or multiple buses may beused, as appropriate, along with multiple memories and types of memory.Also, multiple computing devices 4000 may be connected, with each deviceproviding portions of the necessary operations (e.g., as a server bank,a group of blade servers, or a multi-processor system).

The memory 4004 stores information within the computing device 4000. Inone implementation, the memory 4004 is a volatile memory unit or units.In another implementation, the memory 4004 is a non-volatile memory unitor units. The memory 4004 may also be another form of computer-readablemedium, such as a magnetic or optical disk.

The storage device 4006 is capable of providing mass storage for thecomputing device 4000. In one implementation, the storage device 4006may be or contain a computer-readable medium, such as a floppy diskdevice, a hard disk device, an optical disk device, or a tape device, aflash memory or other similar solid state memory device, or an array ofdevices, including devices in a storage area network or otherconfigurations. A computer program product can be tangibly embodied inan information carrier. The computer program product may also containinstructions that, when executed, perform one or more methods, such asthose described above. The information carrier is a computer- ormachine-readable medium, such as the memory 4004, the storage device4006, or memory on processor 4002.

The high-speed controller 4008 manages bandwidth-intensive operationsfor the computing device 4000, while the low speed controller 4012manages lower bandwidth-intensive operations. Such allocation offunctions is by way of example only. In one implementation, thehigh-speed controller 4008 is coupled to memory 4004, display 4016(e.g., through a graphics processor or accelerator), and to high-speedexpansion ports 4010, which may accept various expansion cards (notshown). In the implementation, low-speed controller 4012 is coupled tostorage device 4006 and low-speed expansion port 4014. The low-speedexpansion port, which may include various communication ports (e.g.,USB, Bluetooth, Ethernet, wireless Ethernet) may be coupled to one ormore input/output devices, such as a keyboard, a pointing device, ascanner, or a networking device such as a switch or router, e.g.,through a network adapter.

The computing device 4000 may be implemented in a number of differentforms, as shown in the figure. For example, it may be implemented as astandard server 4020, or multiple times in a group of such servers. Itmay also be implemented as part of a rack server system 4024. Inaddition, it may be implemented in a personal computer such as a laptopcomputer 4022. Alternatively, components from computing device 4000 maybe combined with other components in a mobile device (not shown), suchas device 4050. Each of such devices may contain one or more ofcomputing device 4000, 4050, and an entire system may be made up ofmultiple computing devices 4000, 4050 communicating with each other.

Computing device 4050 includes a processor 4052, memory 4064, aninput/output device such as a display 4054, a communication interface4066, and a transceiver 4068, among other components. The device 4050may also be provided with a storage device, such as a microdrive orother device, to provide additional storage. Each of the components4050, 4052, 4064, 4054, 4066, and 4068, are interconnected using variousbuses, and several of the components may be mounted on a commonmotherboard or in other manners as appropriate.

The processor 4052 can execute instructions within the computing device4050, including instructions stored in the memory 4064. The processormay be implemented as a chipset of chips that include separate andmultiple analog and digital processors. Additionally, the processor maybe implemented using any of a number of architectures. For example, theprocessor 410 may be a CISC (Complex Instruction Set Computers)processor, a RISC (Reduced Instruction Set Computer) processor, or aMISC (Minimal Instruction Set Computer) processor. The processor mayprovide, for example, for coordination of the other components of thedevice 4050, such as control of user interfaces, applications run bydevice 4050, and wireless communication by device 4050.

Processor 4052 may communicate with a user through control interface4058 and display interface 4056 coupled to a display 4054. The display4054 may be, for example, a TFT (Thin-Film-Transistor Liquid CrystalDisplay) display or an OLED (Organic Light Emitting Diode) display, orother appropriate display technology. The display interface 4056 maycomprise appropriate circuitry for driving the display 4054 to presentgraphical and other information to a user. The control interface 4058may receive commands from a user and convert them for submission to theprocessor 4052. In addition, an external interface 4062 may be providedin communication with processor 4052, so as to enable near areacommunication of device 4050 with other devices. External interface 4062may provide, for example, for wired communication in someimplementations, or for wireless communication in other implementations,and multiple interfaces may also be used.

The memory 4064 stores information within the computing device 4050. Thememory 4064 can be implemented as one or more of a computer-readablemedium or media, a volatile memory unit or units, or a non-volatilememory unit or units. Expansion memory 4074 may also be provided andconnected to device 4050 through expansion interface 4072, which mayinclude, for example, a SIMM (Single In Line Memory Module) cardinterface. Such expansion memory 4074 may provide extra storage spacefor device 4050, or may also store applications or other information fordevice 4050. Specifically, expansion memory 4074 may includeinstructions to carry out or supplement the processes described above,and may include secure information also. Thus, for example, expansionmemory 4074 may be provided as a security module for device 4050, andmay be programmed with instructions that permit secure use of device4050. In addition, secure applications may be provided via the SIMMcards, along with additional information, such as placing identifyinginformation on the SIMM card in a non-hackable manner.

The memory may include, for example, flash memory and/or NVRAM memory,as discussed below. In one implementation, a computer program product istangibly embodied in an information carrier. The computer programproduct contains instructions that, when executed, cause performance ofone or more methods, such as those described above. The informationcarrier is a computer- or machine-readable medium, such as the memory4064, expansion memory 4074, or memory on processor 4052 that may bereceived, for example, over transceiver 4068 or external interface 4062.

Device 4050 may communicate wirelessly through communication interface4066, which may include digital signal processing circuitry wherenecessary. Communication interface 4066 may provide for communicationsunder various modes or protocols, such as GSM voice calls, SMS, EMS, orMMS messaging, CDMA, TDMA, PDC, WCDMA, CDMA2000, or GPRS, among others.Such communication may occur, for example, through radio-frequencytransceiver 4068. In addition, short-range communication may occur, suchas using a Bluetooth, WiFi, or other such transceiver (not shown). Inaddition, GPS (Global Positioning System) receiver module 4070 mayprovide additional navigation- and location-related wireless data todevice 4050, which may be used as appropriate by applications running ondevice 4050.

Device 4050 may also communicate audibly using audio codec 4060, whichmay receive spoken information from a user and convert it to usabledigital information. Audio codec 4060 may likewise generate audiblesound for a user, such as through a speaker, e.g., in a handset ofdevice 4050. Such sound may include sound from voice telephone calls,may include recorded sound (e.g., voice messages, music files, etc.) andmay also include sound generated by applications operating on device4050.

The computing device 4050 may be implemented in a number of differentforms, some of which are shown in the figure. For example, it may beimplemented as a cellular telephone 4080. It may also be implemented aspart of a smartphone 4082, personal digital assistant, or other similarmobile device.

Additionally computing device 4000 or 4050 can include Universal SerialBus (USB) flash drives. The USB flash drives may store operating systemsand other applications. The USB flash drives can include input/outputcomponents, such as a wireless transmitter or USB connector that may beinserted into a USB port of another computing device.

Various implementations of the systems and techniques described here canbe realized in digital electronic circuitry, integrated circuitry,specially designed ASICs (application specific integrated circuits),computer hardware, firmware, software, and/or combinations thereof.These various implementations can include implementation in one or morecomputer programs that are executable and/or interpretable on aprogrammable system including at least one programmable processor, whichmay be special or general purpose, coupled to receive data andinstructions from, and to transmit data and instructions to, a storagesystem, at least one input device, and at least one output device.

These computer programs (also known as programs, software, softwareapplications or code) include machine instructions for a programmableprocessor, and can be implemented in a high-level procedural and/orobject-oriented programming language, and/or in assembly/machinelanguage. As used herein, the terms “machine-readable medium” and“computer-readable medium” refer to any computer program product,apparatus and/or device (e.g., magnetic discs, optical disks, memory,Programmable Logic Devices (PLDs)) used to provide machine instructionsand/or data to a programmable processor.

To provide for interaction with a user, the systems and techniquesdescribed here can be implemented on a computer having a display device(e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor)for displaying information to the user and a keyboard and a pointingdevice (e.g., a mouse or a trackball) by which the user can provideinput to the computer. Other kinds of devices can be used to provide forinteraction with a user as well; for example, feedback provided to theuser can be any form of sensory feedback (e.g., visual feedback,auditory feedback, or tactile feedback); and input from the user can bereceived in any form, including acoustic, speech, or tactile input.

The systems and techniques described here can be implemented in acomputing system that includes a back end component (e.g., as a dataserver), or that includes a middleware component (e.g., an applicationserver), or that includes a front end component (e.g., a client computerhaving a graphical user interface or a Web browser through which a usercan interact with an implementation of the systems and techniquesdescribed here), or any combination of such back end, middleware, orfront end components. The components of the system can be interconnectedby any form or medium of digital data communication (e.g., acommunication network). Examples of communication networks include alocal area network (“LAN”), a wide area network (“WAN”), peer-to-peernetworks (having ad-hoc or static members), grid computinginfrastructures, and the Internet.

The computing system can include clients and servers. A client andserver are generally remote from each other and typically interactthrough a communication network. The relationship of client and serverarises by virtue of computer programs running on the respectivecomputers and having a client-server relationship to each other.

While the inventive features described herein have been described interms of a preferred embodiment for achieving the objectives, it will beappreciated by those skilled in the art that variations may beaccomplished in view of these teachings without deviating from thespirit or scope of the invention.

I claim:
 1. A robotic surgical system for identifying a surgical regionin which to apply an acceptable range of pressures to a functionalportion of a surgical instrument against an animal tissue, the systemcomprising: a surgical instrument having a functional portion thatcontacts an animal tissue having a defined surgical region throughapplication of pressure by an operator of the surgical instrument; arobotic arm configured for holding the surgical instrument andcontacting the functional portion of the surgical instrument with theanimal tissue using a pressure from within a range of acceptablepressures; a pressure application component operably coupled to therobot arm to apply the pressure from within the range of acceptablepressures when contacting the functional portion with the animal tissue;a pressure sensor in an operable association with the functional portionoperable to measure the pressure applied by the operator to thefunctional portion in contact with the animal tissue; a computer havinga processor; and, a memory including a pressure module on anon-transitory computer readable storage medium operable to createpressure data representing the pressure applied by the operator to thefunctional portion in contact with the animal tissue; a design module ona non-transitory computer readable storage medium operable forestablishing a pressure profile output that identifies the range ofacceptable pressures for use in contacting a type of animal tissue, theanimal tissue in contact with the functional portion; a governing moduleon a non-transitory computer readable storage medium, wherein thegoverning module is operable to limit the pressure applied by therobotic arm on the functional portion to the range of acceptablepressures when contacting the functional portion with the animal tissue;wherein the range of acceptable pressures is selected by a process thatincludes analyzing pressure data representing a total range of pressureson a computer having a processor and a memory having a pressure moduleon a non-transitory computer readable storage medium and a database on anon-transitory computer readable storage medium, the analyzing includingcreating the pressure data with the pressure module, the pressure datarepresenting the pressure applied by the operator to the functionalportion in contact with the animal tissue; and, selecting the range ofacceptable of pressures; and, a database on a non-transitory computerreadable storage medium operable to store the pressure data; wherein,the robotic surgical system gathers data to (i) locate tissue borders ofthe surgical site, (ii) identify a preferred pressure, and (iii)transmit the data to the computer to avoid violating the integrity ofthe tissue borders surrounding the surgical site.
 2. The system of claim1, further comprising an input module on a non-transitory computerreadable storage medium for receiving operator input identifying thetype of animal tissue receiving the pressure applied by the operator; atype of function obtained by the functional portion on the animal tissuereceiving the pressure applied by the operator; a type of result,including a positive result and/or a negative result, of the pressureapplied to the functional portion on the animal tissue receiving thepressure applied by the operator; or, a combination thereof.
 3. Thesystem of claim 2, wherein the design module is used to obtain the typeof function, and the positive results, when contacting the functionalportion with the animal tissue.
 4. The system of claim 1, wherein thesurgical instrument is a cutting instrument or a dissecting instrument.5. The system of claim 1, wherein the surgical instrument is a graspinginstrument or a holding instrument.
 6. The system of claim 1, whereinthe surgical instrument is a hemostatic instrument.
 7. The system ofclaim 1, wherein the surgical instrument is a retraction instrument. 8.The system of claim 1, wherein the surgical instrument is atissue-unifying instrument.
 9. The system of claim 1, wherein thefunctional portion of the surgical instrument is configured to removenucleus pulposus tissue.
 10. The system of claim 1, wherein the operatoris a human.
 11. The system of claim 1, wherein the operator is amechanical device.
 12. A method of (i) locating tissue borders of asurgical site, (ii) identifying a preferred pressure, and (iii)transmitting data to a computer to avoid violating the integrity oftissue surrounding the surgical site, the method comprising: obtainingthe robotic surgical system of claim 1; obtaining the surgicalinstrument having one or more sensors to gather data related to thelocation of the tissue borders and/or the preferred pressure, thesensors in communication with the computer; contacting the functionalportion of the surgical instrument with the tissue of the animal with atotal range of pressures; and, analyzing the pressure data representingthe total range of pressures on a computer having a processor and amemory having a pressure module on a non-transitory computer readablestorage medium and a database on a non-transitory computer readablestorage medium, the analyzing including creating the pressure data withthe pressure module, the pressure data representing the pressure appliedby the operator to the functional portion in contact with the animaltissue; and, storing the pressure data on the database; selecting therange of acceptable pressures for use in contacting the functionalportion with the animal tissue; and, transmitting the data gathered onthe location of the tissue borders to avoid violating the integrity ofthe tissue surrounding the surgical site.
 13. The method of claim 12,further comprising correlating operator input with results obtained fromcontacting the functional portion with the animal tissue, thecorrelating including, receiving the operator input with an input moduleon a non-transitory computer readable storage medium; and, identifyingthe type of animal tissue receiving the pressure applied by theoperator; a type of function obtained by the functional portion on theanimal tissue receiving the pressure applied by the operator; a type ofresult, including a positive result and/or a negative result, of thepressure applied through the functional portion on the animal tissue;or, a combination thereof; and, using the data gathered and transmittedto the computer to create a virtual image of a target disc space. 14.The method of claim 13, wherein the animal tissue is a vertebral disc,the border is an annular border, and the method further comprisesdesigning a pressure profile using the design module on thenon-transitory computer readable storage medium operable forestablishing the pressure profile output that identifies the range ofacceptable pressures for use in contacting the type of animal tissue, toobtain the type of function, and the positive results, when contactingthe functional portion with the animal tissue.
 15. A robotic systemcalibrated to identify borders and to apply a range of acceptablepressures to a vertebral disc through a functional portion of a surgicalinstrument, the system comprising: a surgical instrument having afunctional portion; a robotic arm configured for holding the surgicalinstrument and contacting the functional portion of the surgicalinstrument with an animal tissue using a pressure from within a range ofacceptable pressures; a pressure application component operably coupledto the robotic arm to apply the pressure from within the range ofacceptable pressures when contacting the functional portion with theanimal tissue; a processor; and, a memory including a governing moduleon a non-transitory computer readable storage medium, wherein thegoverning module is operable to limit the pressure applied by therobotic arm on the functional portion to the range of acceptablepressures when contacting the functional portion with the animal tissue;wherein the range of acceptable pressures is selected by a process thatincludes analyzing pressure data representing a total range of pressureson a computer having a processor and a memory having a pressure moduleon a non-transitory computer readable storage medium and a database on anon-transitory computer readable storage medium, the analyzing includingcreating the pressure data with the pressure module, the pressure datarepresenting a pressure applied by an operator to the functional portionin contact with the animal tissue; and, selecting the range ofacceptable of pressures; wherein, the robotic surgical system gathersdata to (i) locate the borders of an annulus of the vertebral disc, (ii)identify a preferred pressure, and (iii) transmit the data to thecomputer to avoid violating the integrity of the animal tissuesurrounding the vertebral disc.
 16. The system of claim 15, wherein thesurgical instrument is a cutting instrument or a dissecting instrument.17. The system of claim 15, wherein the surgical instrument is selectedfrom the group consisting of a grasping instrument or a holdinginstrument, a hemostatic instrument, a retraction instrument, and atissue-unifying instrument.
 18. The system of claim 15, wherein theanimal tissue includes intervertebral tissue and cortical portion of avertebral endplate, the functional portion of the surgical instrument isconfigured to remove the intervertebral tissue, and the acceptable rangeof pressures is designed to remove the intervertebral tissue withoutviolating the cortical portion of the vertebral endplate.
 19. A methodof using the system of claim 15 to prepare an intervertebral disc for aspinal fusion procedure, the method comprising creating a point of entryinto an intervertebral disc, the intervertebral disc having a nucleuspulposus surrounded by an annulus fibrosis; obtaining the surgicalinstrument having the functional portion configured for contacting theintervertebral disc with the pressure applied by the operator of thesurgical instrument, the functional portion of the surgical instrumentbeing in an operable association with a pressure sensor for measuringthe pressure applied by the operator to the functional portion incontact with the intervertebral disc one or more sensors to gather datarelated to a location of the borders and/or the preferred pressure, thesensors in communication with the computer; using the one or moresensors to gather data related to the location of the borders of theintervertebral disc and/or the preferred pressure, the sensors incommunication with the computer; and, removing intervertebral tissuefrom within an intervertebral space, the intervertebral space having atop vertebral plate and a bottom vertebral plate while preserving theannulus fibrosis and without violating the integrity of a corticalportion of (i) the top vertebral plate or (ii) the bottom vertebralplate, wherein the removing includes limiting the pressure applied bythe robotic arm on the functional portion of the surgical instrument tothe intervertebral tissue to a pressure from within the range ofacceptable pressures.
 20. The method of claim 19, further comprising:inserting a scaffolding through the point of entry into theintervertebral disc; and, adding a grafting material to theintervertebral space.